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Completed

NCT Number: NCT05099705

Testing a Family Service Navigator Program for Low-resourced Families of Young Children With Autism Spectrum Disorder

The purpose of this study is to develop and test a family navigator training and an app (a technology-based treatment support system) for low-resourced families of young children (aged 3-5) with autism. The hypothesis is that the navigator training and treatment support system will help enable navigators to support families of young children with autism in accessing needed services.

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Key information

Conditions

Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Mental Health Services Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University

Nashville, Tennessee, 37235, United States

About this study

The purpose of this project is to determine whether access to a family service navigator/treatment support system improves outcomes among families of young children (aged 3-5) from low-resourced communities. Pilot work includes interviews and pre/post surveys. Then, a randomized controlled trial will be conducted by randomly assigning families to navigators/treatment support systems or the non-personalized comparison condition (information, training, and referral services). Three-month, six-month, and nine-month follow-up survey data will be collected. Each of the 20 navigators will support two families. Intervention families will have access to the navigator and the treatment support system, which includes a dashboard showing their child's service needs, resources, and a platform to facilitate and document communication between navigators and families. The treatment support system will also allow the navigator supervisor to ensure fidelity of the navigators' support to the family. The statistician will randomize 55 families who meet the inclusionary criteria to each condition--40 individuals will receive navigator/treatment support system (intervention group) and 15 individuals will receive information, training, and referrals (comparison group).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For the families in the clinical trial, there are the following inclusion and exclusion criteria:

Inclusion criteria

  • Be a parent who is in some way from a low-resourced community,
  • Be the parent a child with autism between the ages of 3-5,
  • Be age 18 or older,
  • Want assistance with navigating service delivery systems,
  • Be English speaking or Spanish-speaking,
  • Be able to provide informed consent,
  • Own a phone which can use the treatment support system (or be provided a phone from the Public Assistance Office or from the grant)

Exclusion criteria

-Individuals who do not meet all inclusion criteria are by definition excluded.

For the navigators in the clinical trial, they must meet inclusion and exclusion criteria:

Inclusion criteria

  • Agree to participate in the navigator training and become an navigator,
  • Be a parent who is in some way from a low-resourced community,
  • Be the parent a child with autism who is older than 5,
  • Be age 18 or older, Be English speaking,
  • Be able to provide informed consent,
  • Own a phone which can use the treatment support system (or be provided a phone from the Public Assistance Office or from the grant)

Exclusion criteria

-Individuals who do not meet all inclusion criteria are by definition excluded.

Treatment and study plan

Access to a Family Service Navigator and Treatment Support System

Behavioral

An RCT will be conducted. 40 participants will be randomly assigned to the intervention group and 15 participants to the non-personalized comparison group (i.e., information, training, and referral). The intervention group will have access to a navigator and the treatment support system.

Primary outcomes

  1. Change in Knowledge at 9 months

    Time frame: At the pre-survey and at the nine-month survey

    Called the Autism Knowledge Scale, a multi-item measure examining knowledge of autism services. There are 24 items with higher scores indicating more knowledge. Scale ranges from 0-24.

  2. Change in Skills at 9 months

    Time frame: At the pre-survey and at the nine-month survey

    Called the Comfort with Advocacy Scale, A multi-item measure examining skills to identify, access, and receive services. There are 12 items with higher scores indicating greater advocacy. Scale ranges from 0 to 60.

  3. Change in Advocacy at 9 months

    Time frame: At the pre-survey and at the nine-month survey

    Called the Advocacy Skills Scale, a multi-item measure examining the frequency of advocacy activities. There are nine items with higher scores indicating greater advocacy. Scale ranges from 9 to 45.

  4. Change in Empowerment at 9 months

    Time frame: At the pre-survey and at the nine-month survey

    Called the Family Empowerment Scale, aa multi-item measure examining empowerment in family, services, and community/political environments. There are 34 items with higher scores indicating greater empowerment. Scale ranges from 0 to 136.

  5. Change in Parenting self-efficacy at 9 months

    Time frame: At the pre-survey and at the nine-month survey

    Called the Self-Efficacy scale, a multi-item measure examining competence in parenting. There are nine items with higher scores indicating greater self-efficacy. Scale ranges from 0 to 36.

  6. Change in Service Delivery Outcomes

    Time frame: At the pre-survey and at the three-month, six-month, and nine-month survey

    Called the adapted service measure scale, access to the type, number, and quality of services and unmet service needs. There are over 20 services with higher scores indicating needing greater services. Scale ranges from 0 to 20.

  7. Change in Adaptive and maladaptive behavior at 9 months

    Time frame: At the pre-survey and at the nine-month survey

    Called the Vineland Adaptive Behavior Scale, a multi-item measure examining adaptive and maladaptive behavior. There are 100 items with higher scores indicating greater adaptive behavior. Scale ranges from 0 to 100.

  8. Change in Social responsiveness at 9 months

    Time frame: At the pre-survey and at the nine-month survey

    Called the Social Responsiveness Scale, a multi-item measure to examine social responsiveness. There are sixty items with higher scores indicating greater social responsiveness. Scale ranges from 0 to 180.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 29, 2021
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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